Condition category
Pregnancy and Childbirth
Date applied
14/06/2007
Date assigned
26/06/2007
Last edited
10/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Peng Chiong Tan

ORCID ID

Contact details

Department of Obstetrics & Gynaecology
University of Malaya
Lembah Pantai
Kuala Lumpur
50603
Malaysia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

492.7

Study information

Scientific title

Acronym

Study hypothesis

Pregnant women with an appointment for labour induction at term:
1. Will respond to counseling to have vaginal sex as frequently as possible to promote labour onset, and
2. Spontaneous labour onset rate will increase as result

Ethics approval

Medical Ethics Committee University Malaya Medical Centre, 15/03/2005, ref: HU-61/12/1-1

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Pregnancy: labour induction

Intervention

Counselling to encourage vaginal sex versus no counselling.

Intervention:
1. Counselling by a single investigator (identifiable to women as a doctor) after recruitment
2. Inform women that sexual intercourse is safe and can promote onset of labour
3. Inform women that induced labour is associated with operative delivery and is a more prolonged process compared to spontaneous labour
4. Advise women to have vaginal sex as frequently as possible before their appointment for labour induction to promote labour
5. Ask women to keep a daily diary on vaginal sexual intercourse and any orgasms (marking day when vaginal sex occurs and similarly orgasm if any)

The above intervention/counselling usually takes about 5 to 15 minutes depending on queries. If there are any queries, the response is generally supportive of having sex. The aim is to encourage vaginal sex to promote labour.

Control:
1. Interaction with same investigator
2. Keep session as brief as possible
3. Inform women that sexual intercourse is safe but the effect on labour onset is unclear
4. Ask women to keep diary as above

The above process usually takes about five minutes - most of the time will be on instructions about diary entries. If there are any queries, refer women to standard information leaflet (made available to all trial women - neutral content). The aim is not to influence coital activity in control women.

The intervention comprises of a single counselling session as above. Providers are blind to randomisation. The appointments for labour induction are typically made for within the week ahead. Diaries are collected as soon as possible after delivery. Other outcome measures extracted from clinical notes after delivery. Women who miss their appointment for labour induction are contacted by telephone for information.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Reported coital activity from diary (kept from recruitment to delivery - expected to be only days worth in most instances)
2. Labour onset on or before appointment for labour induction: spontaneous labour (defined as spontaneous uterine contractions resulting in cervical dilatation of at least 3 cm) or pre-labour rupture of membranes on or before appointment date for labour induction

Primary outcomes should typically be resolved within one week of recruitment (no requirement for long term follow up).

Secondary outcome measures

1. Reported orgasms
2. Mode of delivery
3. Recruitment to birth admission interval
4. Initial Bishop Score at the admission for birth
5. Pre-labour rupture of membranes
6. Use of dinoprostone
7. Use of oxytocin infusion during labour
8. Maternal fever
9. Epidural use in labour
10. Meconium stained liquor
11. Delivery blood loss
12. Neonatal admission
13. Apgar score at five minutes
14. Umbilical cord blood pH

Secondary outcomes are events during labour, at delivery or during the usually short hospital confinement after birth. No data is collected after hospital discharge.

Overall trial start date

01/12/2005

Overall trial end date

31/08/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Pregnant women:
1. Given an appointment for non urgent labor induction at term
2. Viable foetus
3. Singleton
4. Cephalic presentation
5. Intact membranes

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

209

Participant exclusion criteria

1. Previous caesarean section
2. Known gross foetal anomaly

Recruitment start date

01/12/2005

Recruitment end date

31/08/2007

Locations

Countries of recruitment

Malaysia

Trial participating centre

Department of Obstetrics & Gynaecology
Kuala Lumpur
50603
Malaysia

Sponsor information

Organisation

University of Malaya Medical Centre (Malaysia)

Sponsor details

Lembah Pantai
Kuala Lumpur
50603
Malaysia

Sponsor type

Hospital/treatment centre

Website

http://www.ummc.edu.my

Funders

Funder type

University/education

Funder name

University of Malaya (Malaysia)

Alternative name(s)

University of Malaya, UM

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Malaysia

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 results in: http://www.ncbi.nlm.nih.gov/pubmed/17906015

Publication citations

  1. Results

    Tan PC, Yow CM, Omar SZ, Effect of coital activity on onset of labor in women scheduled for labor induction: a randomized controlled trial., Obstet Gynecol, 2007, 110, 4, 820-826, doi: 10.1097/01.AOG.0000267201.70965.ec.

Additional files

Editorial Notes